NCT00059826

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

4.3 years

First QC Date

May 6, 2003

Last Update Submit

December 5, 2016

Conditions

Pancreatic Cancer

Keywords

stage I pancreatic cancerstage II pancreatic cancerstage III pancreatic canceradenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

  • Overall survival at 18 months

    at 18 months

Secondary Outcomes (4)

  • Toxicity

    at 18 months

  • Disease-free survival

    at 18 months

  • Local-regional disease control

    at 18 months

  • Distant disease control

    at 18 months

Study Arms (1)

Interferon-based chemoradiation therapy

EXPERIMENTAL

Cycle 1: Chemoradiotherapy (CRT) * 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs * cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36) * IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks * XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks Cycles 2 and 3: Post-CRT Chemotherapy Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3). \-- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest

Biological: interferon-alfa-2bDrug: cisplatinDrug: 5-fluorouracilRadiation: radiation therapy

Interventions

interferon-alfa-2bBIOLOGICAL

IV

Also known as: IFN-alpha-2b
Interferon-based chemoradiation therapy
cisplatinDRUG

IV

Interferon-based chemoradiation therapy
5-fluorouracilDRUG

IV

Also known as: 5-FU
Interferon-based chemoradiation therapy
radiation therapyRADIATION
Also known as: XRT
Interferon-based chemoradiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be \> 18 years of age.
  • Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration.
  • Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system.
  • NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF.
  • Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 \[no residual tumor\] or R1 \[microscopic residual tumor\]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF.
  • Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration:
  • WBC \> 3,000 mm\^3
  • ANC \> 1,500 mm\^3
  • hemoglobin \> 9.5 mg/dl
  • platelet count \> 100,000 mm\^3
  • total bilirubin \< 3 mg/dl
  • AST (SGOT) \< 2.0 times institutional upper limit of normal (ULN)
  • ALT (SGPT) \< 2.0 times institutional ULN
  • alkaline phosphatase \< 2.0 times institutional ULN
  • serum creatinine \< 1.5 times institutional ULN
  • +10 more criteria

You may not qualify if:

  • Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma.
  • Patient is pregnant or lactating.
  • Patient has recurrent pancreatic cancer.
  • Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer.
  • Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis.
  • Patient has received any biologic/ immunologic therapies.
  • Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality.
  • Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Fairview University Medical Center - University Campus

Minneapolis, Minnesota, 55455, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

  • Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2011 Feb;22(2):348-54. doi: 10.1093/annonc/mdq384. Epub 2010 Jul 29.

    PMID: 20670978RESULT

  • Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: initial report of a multicenter, phase II trial of a novel chemoradiation protocol using cisplatin, 5-FU, and alpha- interferon as adjuvant therapy for resected pancreas cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-125, 2008.

    RESULT

  • Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: report on a multicenter, phase II trial for adjuvant therapy of resected pancreatic cancer using cisplatin, 5- FU, and alpha-interferon. [Abstract] J Clin Oncol 26 (Suppl 15): A-4505, 2008.

    RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

IntronsCisplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Vincent J. Picozzi, MD

    Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

March 1, 2003

Primary Completion

July 1, 2007

Study Completion

February 1, 2011

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

US(14)